QMS & Certifications

Earning multiple medical device certifications and quality system approvals are the first step in earning your trust.

RBC is in good standing with many agencies you recognize. We are:

EN ISO 13485:2012 certification by NSAI

EN ISO 9001:2008 certification by NSAI

Applying agency marks for CE, TUV, CSA, South Korea

RBC has developed and implemented a Quality Management System to demonstrate our ability to consistently provide services and products that satisfy our customers, partners, regulatory bodies and other interested parties. We are committed to meeting all applicable requirements and continually improving the effectiveness of the Quality Management System. The Quality Management System reflects the corporation’s total commitment to achieving the goal of meeting the needs of our customers consistently, efficiently and safely.

The objective of RBC Medical Innovations is to provide accurate, on-time and on-budget services and products that satisfy our customers, partners, regulatory bodies and other interested parties. We are committed to meeting all applicable requirements and continually improving the effectiveness of the Quality Management System.

RBC’s certified Quality Management System is based on 21 CFR 820 FDA Regulations, EN ISO 9001:2008 and EN ISO 13485:2012 standards, and the US FDA cGMPs.